Evidence map›Paper›PMID 39048638›Full record

Trial reportBritish journal of cancer2024

COLUMBIA-1: a randomised study of durvalumab plus oleclumab in combination with chemotherapy and bevacizumab in metastatic microsatellite-stable colorectal cancer.

Neil H Segal, Jeanne Tie, Scott Kopetz, Michel Ducreux, Eric Chen, Rodrigo Dienstmann, Antoine Hollebecque, Matthew J Reilley, Elena Elez, Jan Cosaert and 6 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in British journal of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04068610 (A Phase Ib/II, Open-label, Multicenter Study of Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First-line Therapy in Metastatic Microsatellite-stable Colorectal Cancer), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04068610 phase1 / phase2active not recruitingnot on this map

A Phase Ib/II, Open-label, Multicenter Study of Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First-line Therapy in Metastatic Microsatellite-stable Colorectal Cancer (COLUMBIA-1)

TypeinterventionalSponsorMedImmune LLCRan2019 to 2026Enrolled61ConditionsMetastatic Microsatellite-stable Colorectal CancerArmsDurvalumab, Oleclumab, FOLFOX, Bevacizumab
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. Adenosine Kinase: An Epigenetic Modulator and Drug Target.Journal of inherited metabolic disease · 2025
    Review
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Neil H SegalMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Jeanne TiePeter MacCallum Cancer Centre, Melbourne, VIC, Australia.ORCID http://orcid.org/0000-0001-9244-2057
Scott KopetzMD Anderson Cancer Center, Houston, TX, USA.
Michel DucreuxParis-Saclay University, Gustave Roussy Cancer Center, Villejuif, France.ORCID http://orcid.org/0000-0001-8649-7449
Eric ChenPrincess Margaret Cancer Centre, Toronto, ON, Canada.
Rodrigo DienstmannVall d'Hebron University Hospital and Institute of Oncology (VHIO), IOB-Quiron, Barcelona, Spain.ORCID http://orcid.org/0000-0001-5997-318X
Antoine HollebecqueGustave Roussy Cancer Center, Villejuif, France.ORCID http://orcid.org/0000-0003-2869-7551
Matthew J ReilleyUniversity of Virginia Comprehensive Cancer Center, Charlottesville, VA, USA.
Elena ElezVall d'Hebron University Hospital and Institute of Oncology (VHIO), IOB-Quiron, Barcelona, Spain.ORCID http://orcid.org/0000-0002-4653-6324
Jan CosaertAstraZeneca, Cambridge, UK.
Jason CainAstraZeneca, Gaithersburg, MD, USA.
Yee Soo-HooAstraZeneca, Gaithersburg, MD, USA.
Nicola HewsonAstraZeneca, Cambridge, UK.
Zachary A CooperAstraZeneca, Gaithersburg, MD, USA.ORCID http://orcid.org/0000-0003-1059-0940
Rakesh KumarAstraZeneca, Gaithersburg, MD, USA.ORCID http://orcid.org/0000-0002-4627-3667
Josep TaberneroVall d'Hebron University Hospital and Institute of Oncology (VHIO), IOB-Quiron, Barcelona, Spain. jtabernero@vhio.net.ORCID http://orcid.org/0000-0002-2495-8139

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundTo determine whether the addition of durvalumab (anti-PD-L1) and oleclumab (anti-CD73) to standard-of-care treatment (FOLFOX and bevacizumab) enhances the anti-tumour effect in patients with metastatic colorectal cancer (mCRC).

methodsCOLUMBIA-1 (NCT04068610) was a Phase Ib (feasibility; Part 1)/Phase II (randomised; Part 2) trial in patients with treatment-naïve microsatellite stable mCRC. Patients in Part 2 were randomised to receive standard-of-care (control arm) or standard-of-care plus durvalumab and oleclumab (experimental arm). Primary objectives included safety and efficacy.

resultsSeven patients were enrolled in Part 1 and 52 in Part 2 (n = 26 in each arm). Grade ≥3 treatment-emergent adverse events (TEAE) occurred in 80.8% and 65.4% of patients in the control and experimental arms of Part 2, respectively, with 26.9% and 46.3% experiencing serious TEAEs. The confirmed objective response rate (ORR) was numerically higher in the experimental arm compared with the control arm (61.5% [95% confidence interval (CI), 40.6-79.8] vs 46.2% [95% CI, 26.6-66.6]) but did not meet the statistically significant threshold in either arm.

conclusionThe safety profile of FOLFOX and bevacizumab in combination with durvalumab and oleclumab was manageable; however, the efficacy results do not warrant further development of this combination in patients with microsatellite stable mCRC. REGISTRATION: NCT04068610.

Indexed as

Antibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsBevacizumabColorectal NeoplasmsAdultAgedAged, 80 and overFemaleFluorouracilHumansLeucovorinMaleMiddle AgedNeoplasm MetastasisOrganoplatinum CompoundsAntibodies, MonoclonalBevacizumabdurvalumabFluorouracilLeucovorinOrganoplatinum Compounds

Identifiers

PMID39048638
PMCPMC11405658

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.